Overweight or ObesityPhase 1T2DMNCT06615700
Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing NA-931 in people with Overweight or Obesity and Type 2 Diabetes, run by Biomed Industries, Inc. at 2 sites in Australia.
Trial summary
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity, Type 2 Diabetes
- What is being tested?
- NA-931
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesAustralia
- Study dates
- 6 May 2024to 20 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
- Participants must be capable of giving signed informed consent
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
- Willing to comply with contraception requirements
Who cannot join
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- History of alcoholism or drug addiction within 1 year prior to Screening
- Current or recent participation in an investigational clinical trial
- Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Biomed Industries Pty Limited- Clinical Testing Site 1
Camperdown, New South Wales, 2050
Biomed Industries, Pty Limited Testing Site 2
Parkville, Victoria, 3052
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
Read the detailed description
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.
NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
- Conditions
- Overweight or Obesity, Type 2 Diabetes
- Being tested
- NA-931, Placebo
- Keywords
- NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-931Drug
Also called NA-931 is a quadruple receptor agonist
NA-931 is a quadruple receptor agonist for weight loss
PlaceboDrug
Also called Placebo of NA-931
Placebo of NA-931
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm- NA-931 | Experimental | Experimental: NA-931 Capsule of NA-931 intervention Receives: Drug: NA-931 |
| Participant Group/Arm- Placebo | Placebo comparator | Placebo Comparator: Placebo Capsule of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
To evaluate the safety and tolerability of NA-931
Measured: 28 days
Secondary outcomes (2)
Maximum observe drug concentration (Cmax) of NA-931
Pharmacokinetics (PK) Cmax
Measured: 28 days
Effect of a High-Fat Meal on Plasma Concentration of NA-931
Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start6 May 2024
- Primary completion12 Aug 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study director, Biomed Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615700
- Sponsor's protocol ID
- NA-931-50
- Acronym
- T2DM
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06615700
- Acronym / sponsor ID
- T2DM / NA-931-50
- Conditions
- Overweight or Obesity, Type 2 Diabetes
- Keywords
- NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
Detailed description
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.
NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm- NA-931 | Experimental | Drug: NA-931Experimental: NA-931 Capsule of NA-931 intervention |
| Participant Group/Arm- Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: Placebo Capsule of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
- Participants must be capable of giving signed informed consent
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
Key exclusion criteria (5 listed)
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- History of alcoholism or drug addiction within 1 year prior to Screening
- Current or recent participation in an investigational clinical trial
- Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA-931Also: NA-931 is a quadruple receptor agonistNA-931 is a quadruple receptor agonist for weight loss | Drug | Participant Group/Arm- NA-931 |
| PlaceboAlso: Placebo of NA-931Placebo of NA-931 | Drug | Participant Group/Arm- Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
Time frame: 28 days
To evaluate the safety and tolerability of NA-931
2 secondary outcomes
Maximum observe drug concentration (Cmax) of NA-931
Time frame: 28 days
Effect of a High-Fat Meal on Plasma Concentration of NA-931
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lloyd Tran, PhD study director
Biomed Industries, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NA-931 in people with Overweight or Obesity and Type 2 Diabetes, run by Biomed Industries, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events in NA-931 participants (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.